Navigation Links
Johnson & Johnson Provides Update on McNeil Consumer Healthcare Remediation; Announces Completion of Internal Assessment Phase of Comprehensive Action Plan
Date:1/14/2011

NEW BRUNSWICK, N.J., Jan. 14, 2011 /PRNewswire/ -- McNeil Consumer Healthcare Division of McNeil-PPC, Inc., a Johnson & Johnson (NYSE: JNJ) company, in July 2010 submitted to the FDA a Comprehensive Action Plan on quality improvement, and made a commitment to restore its operations to the level of quality and compliance that people expect of all Johnson & Johnson companies. As part of this commitment, McNeil undertook a thorough investigation of historical records, as far back as 2007, for products sold in the U.S. and produced in McNeil's internal manufacturing network.  For each product, McNeil looked at whether the right processes had been identified and followed, and evaluated whether quality standards had been met. This assessment has now been completed, representing a significant milestone in the Comprehensive Action Plan.  

The assessment identified a number of areas for improvement, which are being addressed. For example, McNeil identified instances where equipment cleaning procedures were insufficient or cleaning was not adequately documented. These issues occurred at McNeil's Fort Washington, PA manufacturing plant, prior to April 2010, when production at the facility was suspended. McNeil also discovered one product for which the labeling did not include all information required by regulations.  In line with the company's unqualified commitment to quality and compliance, McNeil today announced a wholesale-level recall of products affected by these issues. (Click HERE to access recall information.) This recall does not come as a result of adverse events.

Johnson & Johnson Chairman and CEO Bill Weldon said, "Steps we have taken under the Comprehensive Action Plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil. They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world."

As a continuing part of this effort, McNeil is conducting assessments at other sites that manufacture its products.  If these reviews reveal any further issues, McNeil will not hesitate to take whatever steps are needed to ensure that its products meet world-class quality standards, including further market action if warranted.

McNeil is committed to ensuring the highest levels of quality, and to restoring recalled products to the market so they will be available to the people who rely on them.  


'/>"/>
SOURCE Johnson & Johnson
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Johnson & Johnson to Provide Webcast Presentation of Tapentadol Phase 3 Clinical Data Presented at American Pain Societys Annual Meeting
2. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
3. Simbionix and Johnson & Johnson LLC Announce Distribution Agreement at Russia and the CIS Countries
4. Johnson & Johnson Announces Support for Kohl-Grassley Physician Payments Sunshine Act of 2009
5. Boston Scientific and Johnson & Johnson Announce Settlement of Patent Disputes
6. Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson
7. U.S. Files Suit Against Johnson & Johnson For Paying Kickbacks to Nations Largest Nursing Home Pharmacy
8. EF Johnson Technologies Announces Third Quarter Results
9. Emerging Agents from Theravance/Astellas, Johnson & Johnson/Basilea and Forest/Astrazeneca/Takeda Will Drive Modest Growth in the MRSA Drug Market Through 2018
10. Johnson & Johnson to Participate in the 30th Annual Cowen and Company Health Care Conference
11. Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 2016 Indiso ltd ... ungedeckten medizinischen Bedarf bei Lungen- und Atemwegserkrankungen ... Forschungsprogramms bekannt. Das Programm, das sich mit ... respiratorischen Funktionen und anderer klinischer Parameter. ... das sich auf den ungedeckten medizinischen Bedarf ...
(Date:2/11/2016)... - Cardiac Marker Diagnostic ... and Cancer Therapy. - European Point of Care ... - Key Diagnostic Testing Markets. - Molecular ... Genetic Testing. - Molecular Diagnostics in Infectious Disease ... Diagnostic Products World Markets. - Point of Care ...
(Date:2/11/2016)... LONDON , Feb. 11, 2016 Stem ... that are characterized by self-renewal and the capacity to ... a relatively new discovery, as the first mouse embryonic ... it was not until 1995 that the first culturing ... pluripotent stem cells were not produced until 2006 As ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... 13, 2016 , ... The National Association for Children of ... representing the growing community of recovering individuals (now over 23 million), to issue ... policies addressing addiction. , Although many of the presidential candidates of both ...
(Date:2/13/2016)... FL (PRWEB) , ... February 13, 2016 , ... The ... environmental impact of American businesses. , The increasingly modern world of instantaneous consumption ... often on non-renewable energy sources such as oil and coal, which pollutes our air, ...
(Date:2/13/2016)... ... ... Au Pair comes all the way around the world to provide child care ... often worried things won’t go well. More often than not, however, they find out their ... Year winner’s all commented how their Au Pairs have become a part of the family, ...
(Date:2/12/2016)... ... February 12, 2016 , ... According to an article published ... for a significant portion of hernia repairs throughout the United States. Commenting on this ... Center notes that this trend has not only been expected, but it seems to ...
(Date:2/12/2016)... Seattle, WA, and Washington, DC (PRWEB) , ... ... ... PATH and the Siemens Foundation today announced a new initiative—the Siemens ... technologies for low-resource settings. The partnership will recruit top students from U.S. ...
Breaking Medicine News(10 mins):